A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
NCT03442764 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2022-08-09
Summary
This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.
Conditions
- Non-obstructive Hypertrophic Cardiomyopathy
Interventions
- DRUG
-
MYK-461
- DRUG
-
Placebo
Sponsors & Collaborators
-
MyoKardia, Inc.
lead INDUSTRY
Principal Investigators
-
Myokardia Medical Information Team · MyoKardia, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-30
- Primary Completion
- 2020-01-07
- Completion
- 2020-01-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
NCT06947590 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
NCT05582395 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
NCT06023186 ·Status: RECRUITING
-
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
NCT07103655 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
NCT06253221 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
NCT06081894 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
NCT05489705 ·Status: RECRUITING
-
Real-World Effectiveness of Mavacamten in Canada
NCT06338202 ·Status: COMPLETED
-
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
NCT07107373 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
NCT07004972 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
NCT06372457 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
NCT04766892 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
NCT05135871 ·Status: COMPLETED ·Phase: PHASE1
-
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
NCT06549608 ·Status: ACTIVE_NOT_RECRUITING
-
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
NCT02842242 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
NCT03153111 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
NCT07023341 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
NCT07210723 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
NCT05767346 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
NCT06412666 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
NCT04164732 ·Status: COMPLETED ·Phase: PHASE2
-
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
NCT06736574 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
NCT03153137 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
NCT04706429 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
NCT01064037 ·Status: TERMINATED ·Phase: PHASE2